Registration Dossier
Registration Dossier
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EC number: 271-516-3 | CAS number: 68583-51-7
Specific investigations: other studies
Administrative data
Link to relevant study record(s)
Description of key information
Repeated application to the ear canal of the rabbit: increase in follicular keratosis.
Additional information
One study investigating the comedogenic properties of Decanoic acid, mixed diesters with octanoic acid and propylene glycol according to "An Improved Rabbit Ear Model for Assessing Comedogenic Substances" is available (Safepharm Laboratories, 1988).
In the study, 3 female rabbits (New Zealand White) were dermally exposed to 0.05 mL of the unchanged test substance applied onto the concave surface of the right ear, just external to the ear canal and well short of the tympanic membrane. The test material was applied for 2 weeks on a 5 days per week basis. A true negative control group, treated with propylene glycol and a positive control group treated with the reference substance isopropylemyristate were included in the testing. The comedogenic potential of the test material was assessed by grading of the follicular keratosis (Grade scale of 0 to 5) and macroscopic examination of hyperkeratosis (Grade scale 0 to 3). The negative control and the positive control substances showed the expected results. In animals treated with the test material, a slight increase in follicular keratosis was noted in 2/3 treated ears (Grade 1 or 2) and microscopic examination revealed moderate hyperkeratosis (Grade 2) in one treated ear. Furthermore, slight hyperkeratosis was microscopically noted in two untreated and two treated ears. A local irritant effect identified by slight erythema, was also noted in one treated ear during the study period. No effect on body weight was noted during the study period in all animals. Following repeated application to the ear canal of the rabbit, and based on clinical and microscopic observations, the test material produced an increase in follicular keratosis. The degree of follicular keratosis produced by the test material was less than that produced by the positive control substance.
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